News & Insights
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FDA Import Refusals FDA’s GRAS Glow-Up FDA Midyear 2026 Review USDA’s Bioengineered Food Disclosure Rules Head Back to the Drawing Board FDA Says: Guard Your Food Facility Registration Like a Password Is Your Brand FDA Acquisition-Ready? The Regulatory Checklist Every Founder Should Complete Before Due Diligence Your Marketing Team Created a Viral Claim. Did They Also Create an FDA Enforcement Risk? FDA Warning Letter, Form 483, or Inspection Observation? Do Not Panic. Do Not Hit Reply. Do This Instead. Your Product Is Detained at the Port. Your Inventory Is Stuck. Your Customers Are Waiting. Now What? The Hidden FDA Problems That Can Destroy Your Next Funding Round, Acquisition, or Exit FDA’s Updated 2026 Human Foods Guidance Agenda Your Wellness Device Is Smarter Than Ever. Is It Still a “Wellness” Product? FDA Form 483 Response Strategy FDA Expands OTC Sunscreen Options FDA Import Detentions, Refusals, and Import Alerts One Day, Big Impact Using AI Tools in FDA Compliance The FDA Called. They’d Like to See Everything MoCRA in Practice Liquidated Damages for FDA‑Regulated Products The Sticky Truth FDA’s PFAS Cosmetics Report FDA Launches Unified Adverse Event Monitoring System (AEMS), Expanding Safety Surveillance and Regulatory Oversight The Color of Compliance Love, Labels, and Selling Self-Care Without Selling an Unapproved Drug Preparing for FDA’s 2026 Human Foods Priorities: Transparency is the New Flavor FDA’s New Cosmetic Recall Power New Year, New Guidance FDA’s Annual Device Registration Renewal Is Back Online — and the Clock Is Ticking to December 31 A Fine Line Between SPF and Soufflé Regulatory Limbo Dashboard Confessional FDA Launches Nationalized Entry Review Program Court Upholds FDA’s Authority Over Homeopathic Drugs, Leaving Industry with Few Remedies Not Quite Food, Not Quite Fiction Stars, Stripes, and Substantiation Knock, Knock, It’s the FDA Crayon Box Clean-Up: FDA Approves Three Natural Food Colors When International Compliance Gets a Pop Quiz! FDA May Be Turning Down the Heat on Inspections, But Food Safety is Still on the Burner Navigating FDA Regulations Amid 2025 Trump-Era Trade Policies Beauty Secrets Revealed The Growing Trend of States to Ban Food Dyes Totally Cool, Inc. Gets the Freeze-Out from the FDA Following Food Safety Violations The Ultimate Permit Tag-Team FDA Doesn’t Send Love Letters Global Implications and Compliance in the Age of MoCRA FDA Revokes Approval for Red No. 3 in Foods and Dietary Supplements FDA’s Regulation and Updated Definition of “Healthy” The FDA’s New Year’s Resolution Say Cheese or Say Trouble? Keeping Fish Fresh and Regulations Fresher Witch’s Brew and Candy Hues Warning Letters Ahoy! Tick Tock, Don’t Get Blocked (Entries)! FDA Investigates Tampon Safety Double Trouble! Herbs, Hocus Pocus and the FDA Fee-Fi-Fo-FDA: New Device Fees on the Horizon! FDA Issues Warning Letters to Companies Selling Delta-8 THC Products in Kid-Friendly Packaging Unlocking International Markets FDA’s Foods Program: A Star-Spangled Update! It’s Getting Hot in Here! Sip Happens FDA FSVP Inspections and Warning Letters on the Rise, oh my! FDA’s New Final Rule on LDTs Blush, Brush and MoCRA! The FDA Import Detention Marathon FDA’s Updated Approach to the 510(k) Premarket Notification Process for Medical Devices Show me the Honey! Don’t Try to Beat this Yellow! FDA’s OTC Monograph Drug User Fee Program FDA’s Import Alert for Chemical Contaminants Including PFAS Streamlining Pathways to FDA Medical Device Market Clearance/Approval Dietary Supplements and New Dietary Ingredient Notifications (NDINs) FDA Medical Device Establishment Registration USDA’s Strengthening Organic Enforcement (SOE) Rule Celebrating Valentine’s Day with Aromatherapy Products or “Love” as an Ingredient in your Granola? A Game of Red Light, Green Light: A Look at FDA Import Alerts Heads Up Medical Device (and Cosmetic Device) Manufacturers and Importers! What’s Coming Down the Pike for Foods and Cosmetics, you ask? MoCRA Readiness How to Initiate and Execute an FDA Recall An Early FDA Holiday Present! FDA Revisiting Classification of Wound Dressings and Liquid Wound Washes A Sprinkle of Holiday (Lead-Free) Cinnamon Spice? Enforcement Delayed by 6 Months Tis the Season for Cosmetic Registration and Product Listing (with a Slight Delay) FDA Issues Eyedrops Products Warning Celebrating Halloween With a Goulish Glow? If it’s Not in Writing, it Doesn’t Exist! It’s that Special Time of Year Again! FDA Device Registration Renewal FDA Releases Updated Draft Guidance Avoid Blushing and Don’t Let GMP Violations Add to Your Highlight Moving the Needle and Modernizing the 510(k) Process FDA Inspections on the Rise Casting a Wider Net for Safer Seafood? Up, Up & Up! Can’t Conceal This! BREAKING NEWS: FDA Issues Draft Guidance on Cosmetic Facility Registration and Product Listing Open Sesame: Updates on Sesame Allergen Labeling CBP Liquidated Damages, Penalties, & Fines…oh my! Cosmetic Facility Requirements: Ensuring Product Manufacturing Success Mid-Summer Grillin’! Fire up the…Cell Incubator? FDA Releases Update for the FDA Foods Program Prep + Prime for MoCRA Summer is for Vacation, not Detention: A Guide to Avoiding FDA Import Refusal and Detention Protecting Your Sunny Side Up FDA Food Allergen Labeling and Cross-Contact USDA VS Permits, PPQ Permits and EANs In Case You Haven’t Heard Ongoing Scrutiny Over Kratom No Cheers with the “The Champagne of Beers” Is My Hand Sanitizer a Food? A Cosmetic? OTC Drug Reform & The CARES Act Infant Formula Market Resiliency FDA Roundup: The Latest Activity FDA Regulation of Human Food Made from Cultured Animal Cells and Updates on FDA’s Imported Seafood Program FDA Roundup: A Look at the Latest FDA Activity Got (Almond, Soy, Oat, Cashew, Pea…) Milk? What you Need to Know about FDA Device Regulation USDA Ushers Organic Regulation Changes for the First Time in Over 30 Years How to Prepare and Execute an FDA Regulated Recall Kicking off the New Year with New FDA Happenings FDA Roundup: A Look at the Latest FDA Activity FDA Flexes Enforcement Muscle FDA’s Proposal for Increasing Color Certification Fees Checking it twice: FDA Facility Registration Renewals! FDA Welcomes 2022/2023 VQIP Participants Factors Constituting FDA Refusal of Inspection FSVP Warning Letters on the Rise FDA’s modernized approach to nutrition Old Europe Cheese’s recall of Brie cheeses Three Cheers for FDA Food Facility Registration Renewal A look at FDA’s Newly Issued Internal Report One, Two, Three Strikes, and you’re…on an FDA Import Alert! Behind the Scenes with ORA Color me Beautifully and Compliantly! The Latest on Cosmetic’s Makeover Family Dollar Announces Voluntary Recall Dietary supplements gone Wild
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Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.